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BioMérieux, Ortho Clinical Diagnostics, iCubate, Others Receive FDA Clearances in June

NEW YORK – In June, the US Food and Drug Administration cleared in vitro diagnostic tests and systems from BioMérieux, Ortho Clinical Diagnostics, iCubate, and Lucid Diagnostics, according to the agency's website.

The FDA cleared BioMérieux's Vitek 2 AST Gram Positive Dalbavancin antimicrobial susceptibility test. The antibiotic dalbavancin is used to treat acute bacterial skin and skin structure infections caused by susceptible gram-positive organisms, including methicillin-resistant Staphylococcus aureus, Enterococcus faecalis (vancomycin-susceptible isolates only), and Streptococcus agalactiae.

Ortho Clinical Diagnostics received clearance for use of its Vitros XT Chemistry Products ALB-TP Slides, a paired albumin and total protein test. The clearance comes on the heels of an FDA clearance in April for the firm's Vitros XT MicroSlides multitest technology and selected assays, which allow labs to run two tests simultaneously on one MicroSlide.

iCubate received FDA 510(k) clearance for use of its iC-GN iC-Cassette running on its iC-System. According to the firm, its iC-GN Assay provides bacterial identification and resistance determination from positive blood cultures and detects eight of the most common gram-negative organisms associated with bloodstream infections and three clinically significant resistance markers.

Also, Serosep received clearance for its EntericBio Dx Assay, a combined panel that includes tests for salmonella, Shiga toxin-producing Escherichia coli, Shigella, Campylobacter, Cryptosporidium, Giardia, Yersinia, Entamoeba histolytica, and Vibrio.

AMS Diagnostics got the go-ahead for its Liasys 600 Electrolyte Measurement System for the measurement of sodium, chloride, and potassium in human serum. AMS also received clearance for its Liasys 600 creatinine reagent, which is used in the diagnosis of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. Further, the FDA cleared the firm's Liasys 600 standalone clinical analyzer.

The FDA cleared Immunodiagnostic Systems' IDS SHBG assay for the measurement of sex hormone binding globulin in human serum and plasma on the firm's IDS System.

Microbiologics received clearances for its Cepheid Xpert SA Nasal Complete Control Panel and its Cepheid Xpert MRSA NxG Control Panel, which are quality control panels designed for Danaher's Cepheid Xpert assays.

Among other clearances, Bühlmann Laboratories got the nod for its fCal Turbo calprotectin test; Lucid Diagnostics received clearance for its EsoCheck Cell Collection Device; and Quidel got clearance for its fluorescence immunoassay test, the Triage TOX Drug Screen, 94600, which simultaneously detects different drug metabolites in urine.

The FDA also cleared Akonni Biosystems' TruDiagnosis molecular diagnostics system and a pharmacogenomics assay to identify genetic signatures associated with metabolism of the blood thinner warfarin, and it granted clearance to Applied BioCode for the use of the Roche MagNa Pure 96 Extraction System with the high-throughput BioCode MDx-3000 and BioCode Gastrointestinal Pathogen Panel.